Back in April, Nexvet Biopharma ($NVET) disappointed investors with the news that its lead compound, NV-01 to treat pain from osteoarthritis in dogs, was not performing well in a pivotal clinical trial and that it would be reassessing the study plan for the drug. On Monday, the company announced that it had completed that trial and, in fact, it met its primary endpoint.
NV-01, an anti-nerve growth factor monoclonal antibody (mAb) that's given as an injection, produced a statistically significant improvement in pain over placebo, as measured by the owners of the dogs in the trial, Nexvet said in a press release. Secondary endpoints, which included the results of validated pain-scoring measurements, were also met.
The data was so compelling the company plans to submit the drug for approval in the U.S. and Europe, it said in the release.
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| Nexvet CEO Mark Heffernan |
"This is a tremendous outcome for Nexvet and we are particularly pleased to receive strong data supporting the long duration of efficacy following a single monthly injection, a key advantage for monoclonal antibody therapies over small molecules," such as non-steroidal anti-inflammatory drugs (NSAIDs), said Mark Heffernan, CEO of Nexvet, in the statement.
Persuading investors that Nexvet can successfully transition from an R&D house to a fully commercial company has not been easy for Heffernan. The Dublin-based company went public at $10 a share in February, below the expected range of $13 to $16, and never gained much traction, closing Friday at $4.88.
The company's short-term fortunes rest on NV-01, the most advanced compound to come out of its PETization platform, a technology it developed to produce species-specific therapeutic antibodies. Nexvet is working on a similar antibody to treat osteoarthritis in cats, called NV-02, and that drug has shown promise in an early-stage trial.
Nexvet planned a conference call for early Monday to discuss the results with Wall Street analysts, and it also promised to reveal further details about its plans for NV-01 at its Animal Health Symposium on Nov. 23 in New York City. But investors didn't need the extra details to reward the company: Nexvet's shares jumped nearly 15% to $5.60 in premarket trading Monday.
- here's the press release